TOLTERODINE NEO TEVA-RATIOPHARM 4 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Tolterodina Neo Teva-ratiopharm

Do not take Tolterodina Neo Teva-ratiopharm

• if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6).

if you are unable to empty your bladder (urinary retention).

• if you have uncontrolled narrow-angle glaucoma (high eye pressure with loss of vision, which is not being treated properly).

if you have myasthenia gravis (excessive muscle weakness).

• if you have severe ulcerative colitis (ulceration and inflammation of the colon).
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tolterodina Neo Teva-ratiopharm:

• if you have difficulty urinating and/or urinate with a weak or slow stream.
• if you have a gastrointestinal disorder that affects the passage and/or digestion of food.
• if you have kidney problems (renal insufficiency).
• if you have liver disease.
• if you have neuronal disorders that affect your blood pressure, intestinal function, or sexual function (any autonomic nervous system neuropathy).
• if you have a hiatus hernia (hernia in an abdominal organ).
• if you ever notice a decrease in bowel movements or have severe constipation (decreased gastrointestinal motility).
• if you have heart disease, such as:
• altered heart rhythm (ECG)
• slow heart rate (bradycardia),
• pre-existing heart diseases such as: cardiomyopathy (weakness of the heart muscle), myocardial ischemia (decreased blood flow to the heart), arrhythmia (alteration of heart rhythm), heart failure

if you have abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Taking Tolterodina Neo Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tolterodine, the active substance in Tolterodina Neo Teva-ratiopharm, may interact with other medicines.

It is not recommended to take tolterodine in combination with:

• certain antibiotics (e.g., erythromycin and clarithromycin).
• medicines used to treat fungal infections (e.g., ketoconazole and itraconazole).

medicines used to treat HIV.

• Tolterodina Neo Teva-ratiopharm should be used with caution when administered in combination with:

certain medicines that affect food transit (e.g., metoclopramide and cisapride).

• medicines for the treatment of irregular heart rhythm (e.g., amiodarone, sotalol, quinidine, and procainamide.
• other medicines that have a similar mode of action to tolterodine (antimuscarinic properties) or medicines that have an opposite mode of action to Tolterodina Neo Teva-ratiopharm (cholinergic properties).

The reduction of gastric motility produced by antimuscarinic medicines may affect the absorption of other medicines.

Taking Tolterodina Neo Teva-ratiopharm with food

Tolterodina Neo Teva-ratiopharm can be taken before, during, or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take Tolterodina Neo Teva-ratiopharm if you are pregnant.

Breastfeeding

It is not known whether tolterodine is excreted in breast milk. Tolterodina Neo Teva-ratiopharm is not recommended during breastfeeding.

Driving and using machines

Tolterodina Neo Teva-ratiopharm may make you feel dizzy, tired, or affect your vision. If you experience any of these symptoms, do not drive or operate heavy machinery.

Tolterodina Neo Teva-ratiopharm contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Tolterodina Neo Teva-ratiopharm

Follow the instructions for administration of this medicine exactly as told by your doctor. Ask your doctor or pharmacist if you are unsure.

Adults

The recommended dose is one 4 mg prolonged-release hard capsule per day.

Patients with liver or kidney problems

In patients with liver or kidney problems, your doctor may reduce the dose to 2 mg of tolterodine per day.

Use in children

Tolterodina Neo Teva-ratiopharm is not recommended for use in children.

Method of administration

The prolonged-release hard capsules are taken orally and should be swallowed whole.

Do not chew the capsules.

Duration of treatment

Your doctor will tell you how long to take Tolterodina Neo Teva-ratiopharm. Do not stop treatment early because you do not see an immediate effect. Your bladder needs time to adapt to this. Finish the treatment with the prolonged-release capsules prescribed by your doctor. If you do not notice any effect, consult your doctor. The benefit of treatment should be reassessed after 2-3 months of use.

If you take more Tolterodina Neo Teva-ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

The symptoms of an overdose include hallucinations, excitement, accelerated heartbeats, dilated pupils, and inability to urinate or breathe normally.

If you forget to take Tolterodina Neo Teva-ratiopharm

If you forget to take the dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with the usual schedule.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tolterodina Neo Teva-ratiopharm

Always consult your doctor if you are thinking of stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should consult your doctor immediately or go to the emergency department if you experience symptoms of angioedema such as:

• swelling of the face, tongue, or pharynx.
• difficulty swallowing.
• hives and difficulty breathing.

Additionally, you should seek medical attention if you experience a hypersensitivity reaction (e.g., itching, rash, hives, and difficulty breathing). This occurs rarely (may affect up to 1 in 100 people).

Tell your doctor immediately or go to the emergency department if you experience:

• chest pain, difficulty breathing, or tiredness (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs rarely (may affect up to 1 in 100 people).

The following side effects have been observed during treatment with tolterodine, with the following frequencies:

Very common side effects(may affect more than 1 in 10 people):

• dry mouth

Common side effects(may affect up to 1 in 10 people):

• sinusitis
• dizziness, drowsiness, headache
• dry eyes, blurred vision
• difficulty digesting (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestines
• difficulty urinating
• diarrhea
• swelling due to fluid accumulation (e.g., in the ankles)
• fatigue

Uncommon side effects(may affect up to 1 in 100 people):

• allergic reactions
• heart failure
• nervousness
• irregular heartbeat, palpitations
• chest pain
• inability to empty the bladder
• tingling sensation in the fingers and toes
• vertigo
• memory impairment

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and dry skin and disorientation. Cases of worsening dementia symptoms have been reported in patients being treated for dementia.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodina Neo Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and blister. The expiry date is the last day of the month stated.

Do not store above 25°C.

HDPE bottle: the validity period after first opening is 200 days.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tolterodina Neo Teva-ratiopharm

• The active substance is tolterodine tartrate.

Each prolonged-release hard capsule contains 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropyl methylcellulose. Capsule composition: Indigo Carmine (E132), titanium dioxide (E171), and gelatin. Coating composition: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-propylene glycol.

Appearance of the product and pack contents

Tolterodina Neo Teva-ratiopharm are prolonged-release hard capsules designed for once-daily administration.

The 4 mg prolonged-release hard capsules of Tolterodina Neo Teva-ratiopharm are light blue to blue opaque.

Tolterodina Neo Teva-ratiopharm 4 mg prolonged-release hard capsules are available in the following pack sizes:

Blisters of 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200, and 280 prolonged-release hard capsules.

HDPE bottles with 30, 60, 100, and 200 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Pharmathen S.A

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

Or

Pharmathen International S.A

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Or

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem Netherlands

Or

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren Germany

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen Hungary

Or

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem Netherlands

Or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80.

31-546, Krakow Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

United Kingdom: Mariosea XL 4 mg prolonged-release capsules

Belgium: Tolterodine Retard Teva 4 mg capsules met verlengde afgifte, hard

Germany: Tolterodin-ratiopharm 4 mg Retardkapseln

Denmark: Tolterodintartrat Teva

Greece: Tolterodine Teva 4 mg καψ?κια παρατεταμ?νης αποδ?σμευσης, σκληρ?

Spain: Tolterodina Neo Teva-ratiopharm 4 mg cápsulas duras de liberación prolongada EFG

Finland: Tolterodin ratiopharm

Ireland: Trusitev 4 mg Prolonged-release Capsules, hard

Luxembourg: Tolterodin-ratiopharm 4 mg Retardkapseln

Netherlands: Tolterodinetartraat retard 4 mg Teva, capsules met verlengde afgifte

Norway: Tolterodine Teva

Poland: Defur

Sweden: Tolterodine Teva

Slovenia: Tolterodin Teva Pharma 4 mg trde kapsule s podaljšanim sprošcanjem

Slovakia: Tolterodin Teva 4 mg

Date of last revision of this leaflet: November 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76778/P_76778.html

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